-NEW- Senior Test Engineer (Medical Devices)
Job Responsibilities:
· Develop and execute comprehensive design verification strategies, plans, protocols, and reports, ensuring full traceability to design inputs, requirements, and acceptance criteria.
· Lead test readiness reviews and design clinically relevant verification methods to ensure appropriate test equipment, fixtures, samples, and procedures are ready for execution.
· Develop, validate, qualify, and maintain test methods, electromechanical fixtures, jigs, test benches, and equipment, including IQ/OQ activities and measurement system assessments.
· Execute design verification, feasibility, reliability, accelerated life, and test-to-failure studies across mechanical, electrical, and system-level designs.
· Analyze test data using appropriate statistical methods, investigate deviations and failures, and prepare clear technical reports and verification summaries.
· Collaborate with R&D, Quality, Regulatory, and Manufacturing teams to characterize new designs, resolve technical issues, and ensure verification readiness throughout product development.
· Maintain audit-ready verification documentation and Design History File (DHF) records while supporting regulatory submissions with required verification evidence and reports.
· Ensure verification activities comply with applicable medical device design controls, quality systems, and standards, including ISO 13485, IEC 60601, and relevant regulatory requirements.
· Adhoc tasks and projects as assigned
Job Requirements
· Minimum Degree in a related discipline
· Minimum 6 year of relevant experience
· Able to start immediately or within short notice
Interested candidates, kindly email your detailed resumes in MS word format to joseph.koh@ambition.com.sg
Attention to Joseph Koh Wei Jie(R1873431)
Shortlisted candidates will be notified
www.ambition.com.sg
EA Registration Number: R1873431
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